Associate Director, Medical Affairs Governance

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Associate Director, Medical Affairs Governance in the United States.

This is a strategic leadership role focused on strengthening governance, compliance, and operational excellence across Medical Affairs. You will design and oversee global governance frameworks, ensuring alignment with regulatory standards and internal policies. The position sits at the intersection of science, compliance, and operations, requiring close collaboration with cross-functional stakeholders across regions. You will lead initiatives related to medical review processes, SOP development, and inspection readiness while driving continuous improvement. This role offers the opportunity to influence global medical strategy and ensure high standards across all activities. It is ideal for a seasoned professional who thrives in complex, regulated environments and is passionate about enabling compliant, high-impact medical operations.

Accountabilities

• Lead the development and implementation of global Medical Affairs governance frameworks and processes
• Oversee Medical Review Committees (MRCs) and ensure compliant review of scientific materials and communications
• Establish and maintain SOPs, work instructions, and best practices to drive consistency and operational excellence
• Partner with Legal, Compliance, Regulatory, and QA teams to ensure adherence to global regulations and internal policies
• Drive inspection readiness efforts, including audit preparation, risk identification, and CAPA implementation
• Provide strategic guidance to leadership on governance, compliance risks, and process improvements
• Ensure alignment of medical activities with regulatory standards such as FDA, EMA, ICH, and industry codes
• Act as a key liaison across functions to harmonize governance practices globally

Requirements

• Advanced degree (PhD, PharmD, MD) preferred; MS or equivalent experience in a related field considered
• 10+ years of experience in Medical Affairs, Medical Operations, Compliance, or Regulatory roles within biotech or pharmaceutical environments
• Strong expertise in global medical governance frameworks, SOP development, and compliance practices
• Deep knowledge of regulatory requirements (FDA, EMA, ICH, GVP, and industry standards)
• Proven experience supporting audits, inspections, and maintaining inspection readiness
• Experience leading Medical Review Committees or similar governance structures
• Excellent communication, leadership, and stakeholder management skills
• Ability to navigate complex regulatory environments and influence cross-functional teams
• Experience in oncology or precision medicine is a plus

Benefits

Competitive base salary range: $177,000 – $221,000 USD

Equity compensation and performance-based incentives

Comprehensive health, dental, and vision insurance

Generous paid time off and flexible work arrangements

Opportunities for professional development and continuous learning

Inclusive, collaborative, and mission-driven work environment

Access to wellness programs and employee support resources

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.